On April 21, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) reported it will present results from three clinical studies, including data from its TROP2 ADC sacituzumab tirumotecan (sac-TMT, 佳泰莱), next-generation selective RET inhibitor lunbotinib fumarate (A400/EP0031, 宁泰莱[1]) and novel ADC SKB500. The abstracts for these studies will be published on the ASCO (Free ASCO Whitepaper) official website on May 21, 2026, local time.

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Detailed information on the studies selected for 2026 ASCO (Free ASCO Whitepaper) is as follows:

Title: Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus pembrolizumab (P) as first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC): Results from the randomized, controlled phase III OptiTROP-Lung05 study
Presentation Type: Oral
Abstract Number: 8506
Session Date and Time: May 29, 3:12 PM-3:24 PM CDT | Lung Cancer-Non-Small Cell Metastatic

Title: Efficacy and safety of lunbotinib (A400/EP0031), a next-generation selective RET inhibitor (SRI), from a pivotal phase Ⅱ study in patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC)
Presentation Type: Oral
Abstract Number: 8505
Session Date and Time: May 29, 2:36 PM-2:48 PM CDT | Lung Cancer-Non-Small Cell Metastatic

Title: An open-label, first-in-human study of SKB500 in patients with locally advanced or metastatic solid tumors
Presentation Type: Rapid oral
Abstract Number: 3011
Session Date and Time: June 2, 9:57 AM-10:03 AM CDT | Molecularly Targeted Agents and Tumor Biology

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting);2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

About A400/EP0031

A400/EP0031 novel next-generation selective RET inhibitor for NSCLC, medullary thyroid cancer (MTC) and other solid tumors with a high prevalence of RET alterations. The NDA of A400/EP0031 has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET-fusion positive locally advanced or metastatic NSCLC. The Company is also conducting a Phase Ib/II clinical study in China for the treatment of RET-positive solid tumors.

In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries. In April 2024, A400/EP0031 was cleared by the Food and Drug Administration (FDA) to progress into a Phase II clinical trial (NCT05443126) which is currently recruiting in the United States, United Kingdom, Europe and United Arab Emirates, where it is being evaluated as a monotherapy and in combination with chemotherapy in RET fusion positive NSCLC.

About SKB500

SKB500, a novel, proprietary ADC developed via the OptiDC platform, is designed to leverage specific target biology through a validated target combined with a differentiated payload-linker strategy. In preclinical investigations, SKB500 demonstrated a favorable therapeutic window with robust efficacy and manageable safety profiles across multiple advanced solid tumors.

Currently, a Phase II exploratory study of SKB500 in combination with immunotherapy with or without chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is ongoing in China.

(Press release, Kelun, APR 21, 2026, View Source [SID1234664630])

On April 21, 2026 Obsidian Therapeutics, Inc., a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, reported an oral presentation of Phase 2 results in patients with advanced melanoma from the Phase 1/2 Agni-01 multicenter study of OBX-115, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, May 29–June 2, 2026.

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Oral Presentation Details:

Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients with advanced melanoma that has progressed on/after immune checkpoint inhibitors (ICI): Phase 2 results
Session Type/Title: Oral Abstract Session – Melanoma/Skin Cancers
Date: Monday, June 1
Abstract Number: 9507
Speaker/Lead Author: Allison S Betof, Division of Oncology, Stanford University School of Medicine, Stanford, CA
Clinical Trial Identifier: NCT06060613

About OBX-115
Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

(Press release, Obsidian Therapeutics, APR 21, 2026, View Source [SID1234664646])

On April 21, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it will provide quality of life data from its Phase 3 COMPETE trial in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held from May 29 – June 2, 2026 in Chicago, Illinois.

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Poster Presentation Details
Title: Quality of life in patients with gastroenteropancreatic neuroendocrine tumors receiving 177Lu-edotreotide or everolimus: Results from the COMPETE study
Abstract Number: 4171
Poster Board Number: 154
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Date and Time: May 30, 2026, 9:00 AM – 12:00 PM CDT
Location: McCormick Place Convention Center, Chicago, IL, USA
Presenter: Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, APR 21, 2026, View Source [SID1234664662])

On April 20, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the poster presentation of additional immunogenicity data from the VB-C-03 clinical trial at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

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The data build on results initially presented at the 10th International Congress on Innovative Approaches in Head & Neck Oncology (ICHNO) in March 2026, which demonstrated a confirmed objective response rate of 38.5% and strong immunogenicity signals. The current results support an even more robust immunogenicity, with now 11 evaluable patients, where all 10 patients (100%) in the 6 and 9 mg dose groups showed HPV16-specific vaccine-induced immune responses. The responses were both rapid and durable, with a demonstrated persistence into the last analyzed timepoint at the completed end-of-treatment.

"The consistency and strength of the T-cell responses we are observing across patients underscore that abi-suva has the makings of a best-in-class vaccine for HPV16-positive cancers. For patients with recurrent or metastatic head and neck cancer, where current treatments offer a response rate of only around 19%, a therapy that can generate this quality of immune response alongside meaningful clinical activity could represent a real step forward. We enter the Abili-T trial with a well-defined dose, a strong immune response profile, and a competitive data package that sets abi-suva apart from other approaches in this indication and we are deeply motivated by the opportunity to make a difference for these patients," said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics.

The poster will be available after the session at the Company’s Webpage: View Source

(Press release, Nykode Therapeutics, APR 20, 2026, View Source [SID1234664545])

On April 20, 2026 Abogen, a clinical-stage biotechnology company focused on RNA innovation, reported preliminary clinical results from the first-in-human (FIH) study of ABO2203 in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The data were presented in an oral session delivered at the AACR (Free AACR Whitepaper) Annual Meeting 2026 in San Diego by Professor Li Wang of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.

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ABO2203 is a lipid nanoparticle (LNP)-formulated mRNA drug candidate encoding a CD3×CD19 bispecific T-cell engager (TCE). By enabling in vivo TCE expression via mRNA, ABO2203 is designed to mitigate cytokine release syndrome (CRS) while maintaining robust clinical efficacy.

The Key to TCE Therapies: Overcoming CRS Toxicity

Nearly all marketed protein-based TCEs carry black-box warnings for CRS, which remains a primary safety challenge in the development of such therapies. While step-up dosing strategies are commonly used to reduce CRS risk, their effectiveness remains limited: Grade 2 CRS still occurs on average in 13%-22% of patients, with some cases requiring hospitalization or even ICU admission. In addition, from the standpoint of drug development, 2-3 years are typically required for dose-finding to determine an appropriate step-up dosing regimen.

These challenges are further amplified when extending TCE therapies beyond oncology into autoimmune diseases. Patients with autoimmune conditions often exhibit heightened immune responsiveness and lower tolerance for adverse events, further raising the safety threshold. Moreover, given the chronic and generally non-life-threatening nature of these diseases, CRS-related risks present significant clinical barriers, particularly in outpatient settings. In autoimmune diseases where long-term disease stability depends on treatment safety, a favorable safety profile may represent a more meaningful competitive advantage than efficacy alone.

Initial Clinical Data: Proof of Concept Validated, with Unlimited Potential

The first‑in‑human trial of ABO2203 in R/R B‑NHL is a dose‑escalation and expansion study. The presentation included data from nine patients in the dose- escalation stage. Patients had received a median of four prior lines of therapy, and all had failed prior CD20‑targeted therapy. ABO2203 was administered subcutaneously across dose levels ranging from 3 μg to 1,920 μg. The maximum tolerated dose (MTD) has not yet been reached.

Exceptional Safety Profile: ABO2203 was well tolerated across all evaluated dose levels. No dose‑limiting toxicities (DLTs), CRS, or ICANS were observed. Elevations in liver enzyme elevations were limited to Grade 1 and occurred at low incidence. The most common adverse event was Grade 1–2 pyrexia, without clinically significant changes in oxygen saturation or blood pressure. Grade 3/4 events were infrequent and primarily hematologic, with no unexpected safety signals beyond those associated with the TCE class or NHL.

Favorable Pharmacokinetics and Pharmacodynamics: TCE expression was detected across all three dose cohorts. The time to peak concentration was gradual after each administration (Tmax = 5.5 days), with a half‑life of 7.9 days. These findings support an initial once-weekly dosing regimen, with the potential to extend dosing intervals to every two weeks following response, and possibly every three to four weeks thereafter.

In contrast to the "pulse‑like" pharmacokinetic profile of protein‑based TCEs, the mRNA‑expressed TCE demonstrated a flatter and more sustained exposure profile. Compared with a protein TCE of identical amino acid sequence (P4107), which reached peak levels and was eliminated rapidly, ABO2203 exhibited a delayed peak TCE concentration and prolonged half-life. The lower peak concentration (Cmax) may help mitigate cytokine release, while sustained mRNA expression may contribute to more durable anti-tumor efficacy than P4107.

Encouraging Efficacy Signals: Based on Lugano 2014 criteria, objective response rates (ORR) were dose-dependent across cohorts, reaching 33%, 67%, and 100% in the low-, medium-, and high-dose groups, respectively. Complete metabolic responses (CMRs) were observed in both the medium- and high-dose cohorts, with a 100% complete response (CR) rate achieved in the high-dose cohort as updated by Professor Li Wang. Responses were seen across both aggressive (DLBCL) and indolent (FL, MCL, MZL) lymphomas, with a 100% ORR in follicular lymphoma.

Compelling Clinical Significance and Commercial Potential

These findings provide initial clinical proof of concept (PoC) for mRNA-encoded TCE therapeutics, demonstrating a superior safety profile, favorable pharmacodynamics, and encouraging efficacy in B-NHL. The data also suggest potential applications in autoimmune diseases. ABO2203’s ability to effectively deplete B cells within lymph nodes may address a well-recognized limitation of conventional CD19/CD20 monoclonal antibodies and existing TCEs in these indications.

The results come amid growing momentum in the TCE field. Since late 2024, the sector has seen increased deal activity, including Merck’s USD 1.3 billion acquisition of CN201 (CD3/CD19) and GSK’s USD 300 million upfront licensing of Chimagen’s trispecific TCE. More recently, Gilead announced a USD 1.675 billion upfront acquisition of Ouro Medicines and its CD3/BCMA bispecific asset, CM336/OM336 this March. With the global TCE market projected to reach USD 121 billion by 2035 (Frost & Sullivan), ABO2203 represents a promising asset in this rapidly expanding category.

(Press release, Abogen Biosciences, APR 20, 2026, View Source [SID1234664562])